Clinical trials: Diabetic Ulcer
Diabetic Foot Ulcer
Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)
This is a Phase 2a Multi-Center, Prospective, Randomized, Controlled Study aimed to evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects with Diabetic Foot Ulcers (DFU)
- Trial name
- NCT06319287
- Testing
- PEP (Purified Exosome Product) / TISSEEL
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Rion Inc.
Diabetic Foot, Diabetic Foot Ulcer
Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers
The feasibility phase of the study was conducted to assess the feasibility of a novel, patient-centered, remote wound management system.
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Wound; Foot, Wound Leg
- Trial name
- NCT05579743
- Testing
- Remote wound monitoring technology
- Where
- United States
- Volunteers
- 148 people
- Sponsor
- Johns Hopkins University
Chronic Wounds, Diabetic Ulcers
Real-world Study of StimLabs Human Placental Membrane Tissue to Treat Hard-to-Heal Wounds
This is a retrospective, multi-center observational study to assess real-world outcomes of StimLabs human placental membrane tissue used in the treatment of hard-to-heal wounds, including chronic ulcers, diabetic foot ulcers…
- Trial name
- NCT07215741
- Where
- 3 sites in United States
- Volunteers
- 23 people
- Sponsor
- StimLabs
Peripheral Arterial Disease, Diabetic Foot Ulcer
Study of PDA-002 in Subjects With Peripheral Arterial Disease and Diabetic Foot Ulcers
This Phase 1, multicenter, open-label, dose-escalation study evaluated the safety and tolerability of intramuscular administration of PDA-002 (human placenta-derived cells) in subjects with peripheral arterial disease (PAD) and…
- Trial name
- NCT01859117
- Testing
- PDA-002
- Where
- 12 sites in United States
- Volunteers
- 15 people
- Sponsor
- Celularity Incorporated
Diabetic Foot Ulcer
Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology
The investigator team will study the adherence of the participant cohort to a non significant risk device over a six month period.
- Trial name
- DFUMAT (NCT05968924)
- Testing
- Podimetrics SmartMat
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Diabetic Foot, Diabetic Ulcer of Left Foot
Crossing the Divide: Piloting Integrated Care to Reduce Amputations Among Rural Patients With Diabetic Foot Ulcers
This project directly addresses the escalating national rate of major (above-ankle) amputations due to diabetic foot ulcers; it focuses on rural patients, who face 37% higher odds of major amputation compared to their urban…
- Conditions
- Diabetic Foot, Diabetic Ulcer of Left Foot, Diabetic Ulcer of Right Foot, Amputation
- Trial name
- NCT05203471
- Testing
- integrated care model
- Where
- United States
- Volunteers
- 131 people
- Sponsor
- University of Wisconsin, Madison
Diabetic Foot Ulcer
Retrospective Record-review Study in Patients Who Had Diabetic Foot Ulcer
The purpose of the study is to evaluate the medical cost of illness for DFUs on the patients who had used ON101 or Aquacel® in the ON101CLCT02 trial.
- Trial name
- NCT05135130
- Testing
- ON101 Cream
- Where
- Taiwan
- Volunteers
- 160 people
- Sponsor
- Oneness Biotech Co., Ltd.
Diabetic Foot Ulcer, Venous Leg Ulcer
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care.
- Trial name
- NCT04927702
- Testing
- Synthetic Hybrid-Scale Fiber Matrix, Standard of Care, Living Cellular Skin Substitute
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Acera Surgical, Inc.
Venous Leg Ulcer, Diabetic Foot
AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period
Study is to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing
- Trial name
- NCT05892341
- Testing
- AQUACEL® Ag+ Extra™, Cutimed® Sorbact®
- Where
- 18 sites in Colombia, Germany and 1 more
- Volunteers
- 203 people
- Sponsor
- ConvaTec Inc.
Diabetic Foot Ulcer (DFU)
Multicentric RCT Comparing High Purity Type I Collagen-Skin Substitute vs dHACM in Treatment of Diabetic Foot Ulcers
This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers at multiple centers. The study intends to compare patient outcome data using Standard of Care with Type-I Collagen-based Skin…
- Trial name
- NCT07046403
- Testing
- High Purity Type-I Collagen-based Skin Substitute and SOC, Dehydrated Human Amnion / Chorion Membrane and SOC
- Where
- 4 sites in India
- Volunteers
- 120 people
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
Diabetic Foot Ulcer (DFU)
High Purity Type I Collagen Based Skin Substitute Vs Dehydrated Human Amnion/Chorion Membrane in Treatment of DFUs
This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers. The study intends to compare patient outcome data using Standard of Care with Type-I Collagen-based Skin Substitute and…
- Trial name
- NCT06470087
- Testing
- SOC and Type-I Collagen-based Skin Substitute, SOC and Human Amnion/Chorion Membrane
- Where
- India
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
Diabetic Foot Ulcer, Ulcer Foot
Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available treatments for diabetic foot wounds.
- Conditions
- Diabetic Foot Ulcer, Ulcer Foot, Diabetic Foot
- Trial name
- NCT06403605
- Testing
- Mirragen Advanced Wound Matrix, Fibracol
- Where
- 15 sites in United States
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- ETS Wound Care, LLC
Diabetic Foot Ulcer
Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers
The purpose of this study is to evaluate the efficacy, safety and economical benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic foot ulcers.
- Trial name
- TWO2DFU (NCT02326337)
- Testing
- TWO2 Device
- Where
- 17 sites in United States, France and 3 more
- Volunteers
- 73 people
- Sponsor
- AOTI Ltd.
Foot Ulcer, Diabetic
Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers
This study will assess the safety and efficacy of using gene therapy via intramuscular injections of the calf for patients with chronic non-healing foot ulcers.
- Trial name
- NCT02563522
- Testing
- Engensis (VM202)
- Where
- 22 sites in United States
- Volunteers
- 44 people
- Sponsor
- Helixmith Co., Ltd.
Diabetic Foot Ulcer
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)
The primary objective of this study is to determine the outcomes of patients who receive a certain type of skin substitute called RestrataTM Wound Matrix (Restrata™).
- Trial name
- NCT03312595
- Testing
- Restrata TM Wound Matrix
- Where
- 5 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Acera Surgical, Inc.
Peripheral Arterial Disease, Peripheral Artery Disease
Implementation of Telemedicine for Patient With Lower Extremity Wounds
The objective of this study is to determine if patients with lower extremity wounds in rural communities who undergo specialty referral through telemedicine have expedited care compared to patients who are treated through…
- Conditions
- Peripheral Arterial Disease, Peripheral Artery Disease, Peripheral Vascular Diseases, Diabetic Foot
- Trial name
- NCT04440839
- Testing
- Telemedicine specialty consultation
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- University of California, Davis
Diabetic Foot, Peripheral Arterial Disease
Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes
In the UK there are over 7,000 leg amputations each year because of diabetes. The most important cause of this is poor circulation. The detection of poor circulation in patients with diabetes is difficult.
- Conditions
- Diabetic Foot, Peripheral Arterial Disease, Diabetic Foot Ulcer, Peripheral Vascular Diseases
- Trial name
- DM PAD (NCT05009602)
- Testing
- Toe Brachial Pressure Index (TBPI), Ankle Brachial Pressure Index (ABPI), Exercise Ankle Brachial Pressure Index (ABPI)
- Where
- 17 sites in United Kingdom
- Volunteers
- 604 people
- Sponsor
- Imperial College London
Foot Ulcer
A Personalized Self-care Support Program for Primary Care Patients With Diabetic Foot Ulcer
This clinical trial aims to learn if a personalized self-care program supporting self-care and Healing through Empowerment and Active Listening (HEALing), is acceptable to patients with diabetic foot ulcer (DFU) and wound care…
- Trial name
- NCT06540170
- Testing
- A personalised self-care support program
- Where
- Singapore
- Volunteers
- 29 people
- Sponsor
- National Healthcare Group Polyclinics
Foot Ulcer, Diabetic
Pressure Alternating Shoes
The project is designed to develop and test Pressure Alternating Shoes (PAS), which will periodically off-load certain regions of the foot in order to prevent foot ulcers.
- Trial name
- PAS (NCT06026813)
- Testing
- test pressure alternating shoes
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Diabetic Foot Ulcer
Clinical Study to Compare Two Skin Substitute Categories for Their Effectiveness to Treat Diabetic Foot Ulcers
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA cleared advanced skin substitute. The commercially available product is Helicoll® Advanced Skin Substitute.
- Trial name
- NCT06557122
- Testing
- SOC and Advanced Bioengineered Skin Substitute, SOC and Active Comparator
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Encoll Corp